Maternal Voice Versus White Noise in Pediatric Surgery

August 22, 2026 updated by: Sinem Öztürkler, Kocaeli University

Maternal Voice Versus White Noise: Effects on Pain, Comfort, and Physiological Responses in Pediatric Surgery

This randomized controlled study will evaluate the effects of maternal voice and white noise on postoperative pain, comfort, and physiological parameters in children aged 1 month to 3 years during the early postoperative period. The study will also compare the effectiveness of maternal voice and white noise in improving these outcomes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

For the maternal voice intervention, the mother will select a lullaby, and its lyrics will be provided to her by the researcher. The lullaby will be recorded in the mother's voice with the assistance of the researcher. The sound level of the recording will be adjusted to approximately 50 decibels. Children assigned to the maternal voice group will listen to the recorded lullaby during the early postoperative period. A copy of the recording will be provided to the mother after completion of the study.

Children assigned to the white noise group will listen to the white noise recording "Don't Let Your Baby Cry 2" from the album "Colic." The recording includes intrauterine-like and white-noise sounds combined with music. The recording will be used after obtaining the necessary permissions from the relevant copyright holders.

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • İ̇zmi̇t
      • Kocaeli, İ̇zmi̇t, Turkey (Türkiye)
        • Kocaeli University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Aged 1 to 3 years
  • Scheduled to undergo an elective minor surgical procedure, such as orchiopexy, hypospadias repair, or hernia repair
  • Undergoing surgery under general anesthesia with an anesthesia duration not exceeding 60 minutes
  • No known hearing impairment
  • No anatomical abnormality of the ear
  • No chronic condition that could affect auditory perception or pain response, such as cerebral palsy, Down syndrome, or another neurodevelopmental disorder
  • Scheduled for direct transfer to the pediatric surgery ward after surgery without an extended stay in the postanesthesia care unit
  • Written informed consent provided by a parent or legal guardian

Exclusion Criteria:

  • Surgery performed under emergency conditions
  • A surgical procedure different from the planned procedure
  • Anesthesia duration exceeding 60 minutes
  • Development of a postoperative complication requiring admission to the postanesthesia care unit or intensive care unit
  • Administration of additional analgesic medication beyond the institutional analgesia protocol
  • Interruption or inability to complete the 60-minute auditory intervention or observation period
  • Withdrawal of consent by the parent or legal guardian

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Maternal voice
Children received routine postoperative nursing care and listened continuously for 60 minutes to a preoperatively recorded lullaby sung by their mother. Playback began after baseline physiological measurements following admission to the pediatric surgery ward. The recording was played through a portable speaker positioned at the head of the child's bed at ear level, with the sound intensity maintained at 50-55 decibels.
Other: Maternal Voice Recording
Before surgery, each mother selected and recorded a lullaby in a quiet room with guidance from the researcher. Following postoperative admission to the pediatric surgery ward, the recording was played continuously to the child for 60 minutes through a portable speaker. Sound intensity was monitored using a calibrated sound-level meter and maintained at 50-55 decibels.
Experimental: White noise
Children received routine postoperative nursing care and listened continuously to a standardized white noise recording for 60 minutes. Playback began after baseline physiological measurements following admission to the pediatric surgery ward. The recording was played through a portable speaker positioned at the head of the child's bed at ear level, with the sound intensity maintained at 50-55 decibels.
Other: White Noise Recording
Children listened to the standardized recording "Don't Let Your Baby Cry 2" from the album "Colic." The recording included intrauterine-like sounds, white-noise frequency components, and accompanying music. It was played continuously for 60 minutes through a portable speaker. Sound intensity was monitored using a calibrated sound-level meter and maintained at 50-55 decibels.
No Intervention: Control Arm
Children received routine postoperative nursing care without a structured auditory intervention. No planned silence or sound restriction was imposed, and the children remained in the usual auditory environment of the pediatric surgery ward. Outcome assessments were conducted at the same time points as in the intervention groups.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative Pain Assessed Using the Face, Legs, Activity, Cry, and Consolability Scale
Time Frame: 30 and 60 minutes after admission to the pediatric surgery ward
Postoperative pain was assessed using the Face, Legs, Activity, Cry, and Consolability Scale. The scale evaluates five behavioral domains: facial expression, leg movement, activity, crying, and consolability. Each domain is scored from 0 to 2, producing a total score ranging from 0 to 10. Higher scores indicate greater postoperative pain and therefore a worse outcome. The scale was administered at 30 and 60 minutes. The prespecified primary endpoint was the total score at 60 minutes.
30 and 60 minutes after admission to the pediatric surgery ward

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative Recovery Assessed Using the Modified Aldrete Recovery Score
Time Frame: 30 and 60 minutes after admission to the pediatric surgery ward
Postoperative recovery was assessed using the Modified Aldrete Recovery Score. The scale evaluates five domains: motor activity, respiration, circulation, consciousness, and peripheral oxygen saturation. Each domain is scored from 0 to 2, producing a total score ranging from 0 to 10. Higher scores indicate a better level of postoperative recovery. A score of 9 or higher generally indicates readiness for discharge from postanesthesia care. The scale was administered at 30 and 60 minutes. The prespecified secondary endpoint was the total score at 60 minutes.
30 and 60 minutes after admission to the pediatric surgery ward
Heart Rate
Time Frame: Immediately after admission and before the intervention, and at 30 and 60 minutes
Heart rate was measured using a pulse oximeter and recorded as beats per minute. Lower values within the age-appropriate physiological range indicate reduced physiological arousal; however, the measure does not have a predefined better or worse direction independently of the clinical context.
Immediately after admission and before the intervention, and at 30 and 60 minutes
Respiratory Rate
Time Frame: Immediately after admission and before the intervention, and at 30 and 60 minutes
Respiratory rate was recorded as breaths per minute. Lower values within the age-appropriate physiological range may indicate reduced physiological arousal; however, the measure does not have a predefined better or worse direction independently of the clinical context.
Immediately after admission and before the intervention, and at 30 and 60 minutes
Peripheral Oxygen Saturation
Time Frame: Immediately after admission and before the intervention, and at 30 and 60 minutes
Peripheral oxygen saturation was measured using a pulse oximeter and recorded as a percentage. Higher values within the clinically expected range indicate better oxygenation.
Immediately after admission and before the intervention, and at 30 and 60 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kocaeli University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2024

Primary Completion (Actual)

January 1, 2025

Study Completion (Actual)

January 1, 2026

Study Registration Dates

First Submitted

June 16, 2026

First Submitted That Met QC Criteria

August 22, 2026

First Posted (Actual)

August 25, 2026

Study Record Updates

Last Update Posted (Actual)

August 25, 2026

Last Update Submitted That Met QC Criteria

August 22, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023/361

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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